Revisiting Seroxat Withdrawal

One has to ask why manufacturers of products choose to ignore negative news and fail to warn the public about possible side effects of a product they manufacture.

I've been writing and researching GlaxoSmithKline for over ten years now, some would suggest that I have a bias when writing about them, in as much that I only ever write about their dirty deeds and not the 'good' side of Glaxo.

Thing is, I don't really see anything positive coming out of GlaxoSmithKline, even when it does one will find there's usually something underhand hidden in the good news that they preach. They team up with children's charities and that, to an outsider, makes them look really caring - the same outsider will quickly forget about the potential millions of children Glaxo put at risk when promoting Seroxat off-label to this vulnerable population. Yeh, we have to forgive at times, maybe just move on and forget but it's hard to do where Glaxo are concerned.

My time on Seroxat and subsequent withdrawal from it is well documented both on this blog and in my book (The evidence, however, is clear, the Seroxat scandal) I'm one of many thousands that struggled to wean off Seroxat - many of those thousands have been compensated by GlaxoSmithKline, in fact over 3,000 consumers in America were paid by Glaxo in an out-of-court settlement - in other words, they were paid and had to sign confidentiality agreements whereby they couldn't tell anyone exactly how much Glaxo paid them. Glaxo also admitted no liability, which basically means they can say that Seroxat did not cause addiction in those 3,000+ consumers - they can stick to the line that it takes roughly two weeks to safely withdraw from Seroxat. Glaxo can and will always claim that "We believe the product is not defective and that there is therefore no merit in this litigation." - I am refering to the on-going UK litigation here.

Below is a document I found online, I've posted it before on here and even tweeted it to GSK and their lawyers. The document is a series of emails regarding a clinical trial, better known as "Project 1059."

Project 1059 saw James Ballenger, MD carrying out a long-term panic disorder study in 2000, Seroxat was the choice of drug. The study was cancelled by GlaxoSmithKline (then SmithKline Beecham) after they learned that Ballenger's findings had found something that they wanted to keep quiet.

As with most clinical trials, the finding are written up by ghostwriters. The series of emails below shows how they (the ghostwriters) couldn't turn bad news in to good news. This is quite rare, particularly with Seroxat, as some years previous Glaxo had managed to turn bad news in to good regarding Study 329  - In a nutshell, that study showed Seroxat was no more effective than placebo in kids and, more importantly caused a significantly high amount of kids to have suicidal thinking.

Anyway, back to Project 1059. James Ballenger, MD had found that many people in his study were suffering when trying to stop Seroxat. This was bad news for Glaxo, so bad that they actually pulled the study. The emails below are from Daniel Burnham of SmithKline Beecham to ghostwriter Sally K. Laden who, ironically, was also at the forefront of turning the bad news of Study 329 in to good news.

 Daniel Burnham of SmithKline Beecham writes...

"The issue of discontinuation sx [side effects] vs. relapse is obviously a concern of the J Clinical Psychiatry reviewers... Thus we have decided to terminate further work on this manuscript."

The industry prefer to call withdrawal issues "discontinuation problems".

What is striking about this correspondence is Laden's response to Burnham...

“We understand your reasons for cancelling this project. There are some data that no amount of spin will fix, and these certainly fall into this category.”

So, after learning that a number of people in Project 1059 were having trouble withdrawing from Seroxat, Glaxo, knowing that this could affect potential sales, decided to pull the plug on the study, in other words they would bury the data and thus keep Seroxat in the public eye as the best antidepressant on the market that had only 'minimal' side effects.

It's important that these emails are spread far and wide - they have been publicly available for a few years now and will more than likely be used as evidence in the UK Seroxat litigation. I mean, what Judge could say that the emails below don't really prove that Glaxo knew about the withdrawal problems with Seroxat?

Here's the internal emails.

Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. Glaxo, as you would imagine, wanted the Judge to throw out the claims that Seroxat caused withdrawal effects in UK consumers.

In his judgment (1), Mr. Justice Foskett said...

"Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a "putative class action" consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged "discontinuation symptoms." In January 2012 a class-wide settlement with no admission of liability was achieved. Again, the claims would have gone to a jury trial in the absence of settlement."

I'm almost certain GlaxoSmithKline will try to defend Seroxat and make claims that they have evidence that Seroxat does not cause severe withdrawal problems - I'm really looking forward to seeing that evidence because after 10 years of writing and researching GlaxoSmithKline I have not once been able to find any such evidence, in fact the only evidence I've found publicly is internal emails produced in US litigation regarding Seroxat and birth defects, suicide and withdrawal problems. If Glaxo can produce evidence that shows there really is no problem when discontinuing Seroxat then I will, as a show of good will, stop blogging and move on to something else.

Your move, Glaxo!

Bob Fiddaman.

Glaxo Blew It!

"You had your chance and you blew it." ~ Robert De Niro

I don't suppose for one minute that the likes of Andrew Witty (GlaxoSmithKline) would ever take advice from a 51 year-old blogger from Birmingham - to be honest I don't care if he takes it - I'm offering this for free, it's not just for Witty, it's for other pharmaceutical company CEO's who, for whatever reason, think that problems raised can easily be swept under the carpet.

I've been writing this blog for almost ten years now, the research that goes into many of the blog posts I write can be, at times, very time consuming, none more so when it comes to GlaxoSmithKline who, for one reason or another, always seem to be grabbing the headlines in the international press. If they aren't paying out settlements for fraud, they are being accused of fraud - it's a never-ending trail of cancerous cells that just can't be obliterated.

The latest in Glaxo's long history of popping in and out of court rooms is the alleged claim that Seroxat causes severe withdrawal problems - surely not?

One only has to enter the search terms 'Seroxat + withdrawal+addiction' into Google to find out how Glaxo, who monitor what is said about their products, actually do nothing when faced with a barrage of criticism from patients (nae consumers) - ie; they don't address a problem when it arises, they ignore it because they know to engage with patients can be detrimental to the business, ergo can damage sales.

That's where they are going wrong.

Glaxo have had ten years to sort out the problem British patients have been facing with their (once) best-selling antidepressant Seroxat - truth is, they have done nothing about the reported adverse reactions or rather they, just like the British drug regulator, the MHRA, shrugged their shoulders at them. What's a couple of hundred people suffering on a product compared to those who say nothing, anyway?

There's the old 'ignore them and they will go away' factor that comes into play here too. The MHRA and GlaxoSmithKline take this approach, again, this is where they go wrong.

Do you think I would have dedicated almost ten years of my life to researching and writing about pharmaceutical companies and medicine regulators if they had opened their doors to me and shown me how I was wrong and they were right? Of course to do so would mean they would have to summon the evidence that I was wrong - they haven't and they can't.

This isn't me being obstinate or, as the MHRA like to call me, vexatious. This is plain and simple - they refuse to engage with me and people like me because we are question-askers, we ask the right questions and we are not guided by lawyers or editors who tell us that we can't ask this or that.

It's about transparency and I've yet to see any transparency from GlaxoSmithKline or from any other pharmaceutical company come to that.

Now, all that is about to change. News early last month that the UK Seroxat litigation can proceed to trial must have come as a blow to GlaxoSmithKline because those very same questions that they have been avoiding will be asked in an open court, complete with a public gallery. Glaxo, via their lawyers, had previously asked the Judge to halt the trial, citing various reasons. The Honorable Mr Justice Foskett denied them this (Full 31 page ruling here)

Documents will be, for the first time, aired to the British public. All and sundry (including health care professionals) will be able to read about the severity of Seroxat withdrawal. Those same people will learn that, for years, Glaxo denied this even though they knew about it. (See Seroxat - Project 1059 Laden With Withdrawal Problems)

It's vindication for those who have suffered severe withdrawal effects of Seroxat, worse still for those that still are. How many of these people have had to try and tell their husbands or wives that they just don't know why they are suffering these crazy symptoms? How many of those that have suffered have endured the opinions of their health care professionals telling them, "It's the illness and not the drug"? How many have had to explain to their children why they are suffering electric zap sensations and that their brains feel like they are frying? Perhaps those who have suffered have had to explain to their kids why 'mommy and daddy' can no longer live together or why they can't have the Christmas presents they asked for because the crazy withdrawal from the medicine keeps them in bed or doubled up in the fetal position for hours on end, "That's the reason why I lost my job, son." Maybe they've had to apologise to their children for losing their temper on them (aggression being yet another side-effect of withdrawing from Seroxat) - If only Glaxo would have been truthful, huh?

GlaxoSmithKline, as I said, have had almost ten years to hold up their hands and admit that they got it wrong - they chose not too because they thought the problem would go away. Back in 2011 Witty was approached and asked if he would meet the Seroxat Users Group to discuss the very same thing they now find themselves defending in court - the Seroxat withdrawal issue - he declined (See GSK's Andrew Witty in Patient Aftercare Snub)

Truth is, bloggers tend to get the bit between their teeth because they sense a great injustice has been done - then, as they plod along, year after year, they find that this is not just an individual problem, there are more people out there suffering, not just the horrific withdrawals either - suicide, self-harming, birth defects are just three of the many reported adverse events associated with Seroxat.

In the early 2000's Glaxo settled out of court with over 3,500 American consumers who claimed Seroxat had caused serious withdrawal problems. They did so with confidentiality agreements, also known as "gagging orders". Pharmaceutical companies do this to suppress the truth, it's also what litigation is all about - it keeps those documents (previously unseen) away from the public, press and healthcare professionals.

It very much looks like those documents may just see the light of day in the UK as 105 consumers of Seroxat head to court later this year. I, for one, can't wait to finally see that I have been correct all along and that Glaxo have not only being keeping the secrets of Seroxat away from me but from others too, including my doctor and your doctor.

I'm echoing here what a fellow blogger has wrote over at Seroxat Secrets. He pretty much hits the nail on the head with, "...And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?"

Of course it could go either way, not, as I suspect, on evidence provided though. Glaxo's representative lawyers, Addleshaw Goddard LLP, will have already tactically planned how they wish to defend these allegations be it by dragging out the case for as long as they can in the hope that the claimants will have their funding dry up. Sadly, for Addleshaw Goddard that is, this isn't an option. Funding is in place and, according to The Honorable Mr Justice Foskett, assurances have been given that the claimants have more funding should the need arise. A tactic of big corporations is to drag out cases for as long as possible, it's a great tactic because it means eventually the small man will have to back down. All the time the fat-cat lawyers are getting paid by those they represent, a win-win situation. It appears the latest judgment by The Honorable Mr Justice Foskett will not allow this to happen. Round One, it appears, to the claimants.

Then, of course, Addleshaw would have been going through precedents to see if they can get the case thrown out because a ruling made by Judge X in the year XXXX. That's their job, to defend the indefensible...by any means.

Glaxo defence lawyers may or may not throw a curve-ball, they may plead with the Judge that the documents presented in court are sensitive therefore should not be made public - it appears as though it's a gamble they are prepared to take which means correspondence between themselves and the MHRA will be "outed" as they say. If they are going to go down then why not drag the limp-wristed medicines regulator with them, huh?

It's been almost 10 years in the making.

Eat your heart out John Grisham.

Bring it on.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)


Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.

Seroxat Withdrawal Litigation

Judgment has been received from the Honourable Mr. Justice Foskett to proceed with the Seroxat Withdrawal Group Litigation. Any of the group Claimants who have not received forms from Fortitude Law in the past 2 weeks should contact Fortitude Law via email at sjrichards@fortitudelaw.uk or telephone on 0203 667 3775 without delay.

Bob Fiddaman.

Exclusive: UK Seroxat Litigation to Press Ahead

FOR IMMEDIATE RELEASE

Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. (1)

Defendants, GlaxoSmithKline, sought an order that would have had the effect of bringing these proceedings to a permanent halt.

In arriving at his conclusion to not grant GlaxoSmithKline their order, Mr. Justice Foskett said...

"The Defendant is anxious (it might be said, over-anxious) to stop this litigation in its tracks. The motivation may simply be a total conviction that there is, in effect, no case to answer and that it is wrong to be harassed with unmeritorious claims. Alternatively, it may derive simply from a desire not to have to face in this jurisdiction the kind of claims brought in the USA and elsewhere. It may, of course, be a combination of both."

Mr. Justice Foskett had previously asked both parties to supply him with a summary of other litigation throughout the world concerning Paroxetine. In his Judgement Mr. Justice Foskett said...

"Although the list of actions provided to me on behalf of the Claimants is longer than that provided by the Defendant, a cursory comparison suggests that they largely cover the same material. Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a "putative class action" consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged "discontinuation symptoms." In January 2012 a class-wide settlement with no admission of liability was achieved. Again, the claims would have gone to a jury trial in the absence of settlement."

It's good to see this on-going litigation finally get the thumbs-up to move forward to trial, and in my view the Honorable Mr Justice Foskett has to be applauded here for meticulously combing through arguments from both parties.

Mr Justice Foskett's Judgment seems to have paved the way for both parties to, at the very least, now plan where they are going with this.


The case between: SANDRA BAILEY AND OTHERS (Claimants) and  GLAXOSMITHKLINE (UK) LIMITED (Defendant) will now proceed to trial.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)

Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.



Declaration of Interests: I am one of the claimants.

(1) Bailey & Ors v Glaxosmithkline (UK) Ltd [2016] EWHC 178 (QB) (04 February 2016) 

Seroxat - Project 1059 Laden With Withdrawal Problems

GlaxoSmithKline are defending allegations that it's antidepressant, Seroxat, known as Paxil in the US, causes severe withdrawal reactions when patients have tried to taper of of it. They have settled similar allegations in the US with over 3,000 claimants, all of whom went on to sign confidentiality agreements - the official line of that particular case was that it was "resolved."

Later this year sees GlaxoSmithKline defend the same allegations, this time in the UK. The case has been running for 8 years plus and at no time have GlaxoSmithKline, via their representative lawyers, Addleshaw Goddard, made any offer of settlement to the 105 plaintiffs in the case.

So, there's a kind of stale-mate. 105 claimants allege they suffered severe withdrawal reactions when trying to wean themselves from Seroxat - Glaxo have maintained that "We believe the product is not defective and that there is therefore no merit in this litigation."

No merit?

Let's go back in time, to the year 2000.

James Ballenger, MD, was chair of the Medical University of South Carolina’s Department of Psychiatry, and he had been carrying out a long-term panic disorder study in 2000, Seroxat was the choice of drug. The study was cancelled by GlaxoSmithKline (then SmithKline Beecham) after they learned that Ballenger's findings had found something that they wanted to keep quiet - Severe withdrawal effects in adults that take them!


"There are some data that no amount of spin will fix."

As with most clinical studies, Glaxo had, just like they did in Study 329, hired a ghostwriter to draft the positive results from Ballenger's study.

Once again, just as in Glaxo's infamous 329 study, Sally K. Laden was handed the job of turning bad into good. Sadly, for Glaxo at least, even Laden couldn't spin the results of Ballenger's study, (known as "project 1059")

Internal emails between Laden and Daniel Burnham of SmithKline Beecham show Burnham write the following...

"The issue of discontinuation sx [side effects] vs. relapse is obviously a concern of the J Clinical Psychiatry reviewers... Thus we have decided to terminate further work on this manuscript."

The industry prefer to call withdrawal issues "discontinuation problems".

What is striking about this correspondence is Laden's response to Burnham...

“We understand your reasons for cancelling this project. There are some data that no amount of spin will fix, and these certainly fall into this category.”

This, to me at least, suggests that Laden was familiar with spinning poor results into bad.

Laden then told her bosses at Scientific Therapeutics Information, Inc. (STI)...

“Yes, Virginia, there is a God. SB cancelled our project 1059 (long term panic disorder study). Reason: the side effect data was terribly unfavorable to our favorite antidepressant. And we hate when that happens!”

Definition of 'terribly' -  very, extremely, hugely, intensely, immensely, dreadfully, incredibly, extraordinarily, seriously.


In a 2012 interview with investigative journalist Dyan Neary, Ballenger said...

“What that study in retrospect probably showed for the first time was that there’s withdrawal from the medicine…your body might miss it.”

Hmm, dependency anyone?

Question we really should be asking here is why didn't GlaxoSmithKline, when they knew of the severe withdrawal problems, carry out their own study into these problems raised in Ballenger's study? Why did they sit on this information? Myself, and others, would then not have had to endure the horrific withdrawal problems - had myself, and others, had previously know about these "terrible" side effects, we would never had taken Seroxat.

The prosecution rests, m'lud.

Here's the emails. (Click to enlarge)

Something for Glaxo's UK lawyers, Addleshaw Goddard, to mull over, perhaps.

Bob Fiddaman.

Competing interests

I am one of the 105 claimants in the UK group action.

C-Day for Eli Lilly

I do love it when pharmaceutical companies enter into trials (litigation) in the small hope that they can persuade judges to toss cases on points of law.

Litigation fascinates me and it's something that has been very much part of my reading materiel over the past few years or so. I should have studied law, I guess it's never too late - sadly I have the memory of a sieve and don't think I could soak and retain any information given to me... and then sit a bar exam. So, it's just a hobby of mine to read through court transcripts and depositions.

There are many stages of litigation before it actually gets into court. In the main, both sides try and strike a deal that will suit both parties, those making the claim and those defending the claim. Pharmaceutical attorneys are in the business of saving their clients money so they will do pretty much everything in their power to make it difficult for plaintiffs. America is different to the UK in the respect that Pharmaceutical companies, when facing group actions (class-action lawsuits) try to consolidate them all so they are heard in a specific state, a state that may have a different set of rules (laws) than any other state, a state that normally gives them a better chance of success (due to favourable laws)

Pharmaceutical attorneys also apply for "Summary Judgement". In a nutshell this means that they apply to a judge and ask him to strike the cases against them because, "they will argue that no factual issues remain to be tried and therefore a cause of action or all causes of action in a complaint can be decided upon certain facts without trial."


One recent motion for "Summary Judgement" came in the cases Herrera v. Eli Lilly and Company (case no. 2:13-cv-2702-SVW-MAN) and Hexum v. Eli Lilly and Company (case no. 2:13-cv-2701-SVW-MAN)

Eli Lilly and Company are defending cases brought against them regarding their antidepressant, Cymbalta. The crux of the claim is that Lilly failed to adequately warn the plaintiffs and their physicians of Cymbalta’s true withdrawal risks. Lilly filed a motion for "Summary Judgement" and the judge (Judge Stephen V. Wilson, U.S. District Court for the Central District of California, Los Angeles) denied them this motion. Now, Lilly go to trial to face the allegations and, more than likely, they will use points of law throughout the trial, or rather they will exhaust every single avenue to try and get the cases dismissed. If this doesn't show the average person how guilty they are then I don't know what will.

The beauty of this trial is that Lilly are up against a formidable team in Baum, Hedlund, Aristei & Goldman. The Los Angeles based law firm have quite a history when going up against pharmaceutical companies. They, along with three other law firms are representing over 2,000 plaintiffs who allege they have suffered injury, and in some cases, death, due to symptoms suffered while attempting to discontinue Cymbalta.

Cymbalta has been prescribed widely and there have been many reports of severe withdrawal reactions to it. Lilly, just like other antidepressant manufacturers, chose to either ignore these reports or, as the case may be, play down the reactions, ie; blame the illness rather than the product. It's a classic stance of the pharmaceutical industry and, it has to be said, a classic stance of those who regulate prescription medications (FDA). You can judge for yourselves if you think it's difficult to taper from Cymbalta, here.

These cases are ones that I shall be keeping tabs on. The first starts Tuesday Aug. 4 in Los Angeles.

Oh to be living in California right now. I'd pretty much drop everything to be present at trial, I'd pretty much like to see Baum, Hedlund, Aristei & Goldman in action and Lilly attorneys too.

I like a flutter now and again - I'm betting that Lilly will, at some point during these series of group actions, cave in and settle. First though, they must try to find legal loopholes to avoid paying out millions of dollars, those dollars being the profit they have made on Cymbalta. Profit that came about due to their failure to warn against the horrific withdrawal reactions many have had to endure.

Let's get these items of disclosure out into the public domain, let's see how Lilly played down the risk.

Yup, I do love it when Pharmaceutical companies refuse to offer settlement. It makes blogging such a pleasure and enlightens and educates me.

Sad, I know but, hey-ho, some folks like to knit, some like to go to the gym.

I like to read and disseminate information regarding the dangers of these drugs and the way that pharmaceutical companies, such as Lilly, hold back information from the public purely to keep their pockets bulging and to keep their shareholders happy.

More coming soon.


Bob Fiddaman.

UK Seroxat Litigation Update - June 2015

Many of the Seroxat Claimants have received notice this week that unless the Group Action secures funding soon the case against GlaxoSmithKline will be struck out of Court. For those of you who have received the Court Order through the post, don't panic, there is no need to do anything.

Solicitors, funders and insurers are putting together a funding package with no risk of exposure to costs to you and will be filing this in Court.

There really is nothing more to add publicly but if you want further information please contact me here. (No media)

Let battle commence.


Bob Fiddaman

Cymbalta - Australian Doctor's Warned

A subscription only based website aimed at Australian healthcare professionals is reporting that doctors in Australia are being urged to prescribe Eli Lilly's antidepressant Cymbalta (duloxetine) with caution after a 35-year-old Victorian truck driver died of serotonin syndrome from a dose increase.

Nicholas Moorby died in April 2013, four months after his GP increased his Cymbalta dose from the recommended maximum daily dose of 120mg (three 60 mg capsules) to 240mg/4 capsules per day.

According to the Australian Doctor website, "friends of Mr Moorby noticed he was "agitated", "really out of it", "blabbering" and "making no sense" in the days leading up to his death."

Moorby's GP, who increased the dose, admitted that he had made an "error of judgement" and did not face any criminal charges over the death.

This from the Australian Doctor:

His GP was told by Mr Moorby that his psychiatrist recommended the dose increase due to his severe depression. The unnamed GP told the told the Coroners Court of Victoria last month,“Unfortunately, a lot of the specialists nowadays do not write scripts, they would tell the patient, go and see your GP and get the GP to write them. There are many cases where specialists prescribe big doses of anti-depressive so while I go to one or two tablets it’s not unusual for specialists to go to four, so I did not question him on that,” 

Moorby had amphetamine, methamphetamine, duloxetine, oxycodone, promethazine and alcohol in his system when he died. However, Forensic pathologist, Dr Heinrich Bouwer, told the court that an adverse drug reaction to excessive duloxetine could occur with or without the interaction of amphetamines.

The Australian medicines regulator, The Therapeutic Goods Administration, recorded 21 cases of serotonin syndrome due to duloxetine in their Dec 2013 report.

For those that don't know, serotonin syndrome, also known as serotonin toxicity, is a  life threatening drug reaction that causes the body to have too much serotonin. This leads to excessive stimulation of the central nervous system and peripheral serotonin receptors.

When you take poor metabolizers into account and you see what the friends of Nicholas Moorby said... he was "agitated", "really out of it", "blabbering" and "making no sense"  - there really is a strong argument that these drugs can induce suicide and homicidal acts. Alas, the pharmaceutical companies and the blinkered views of psychiatrists often blame the "underlying illness" for the cause of suicide and/or homicide.

In the United States Eli Lilly and Company are facing a number of lawsuits regarding Cymbalta.

Over 20 lawsuits have been filed in federal courts across the US which sees claims that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials.

More information about those lawsuits can be found on the Baum, Hedlund, Aristei & Goldman, P.C here.

Bob Fiddaman.

Cymbalta Beads

I was reading through the comments section of an online Cymbalta withdrawal support group yesterday.

'Cymbalta Hurts Worse' is a Facebook support group where readers offer advice in getting off Cymbalta. Reading through brought back so many memories of my time on Seroxat [known as Paxil in the US]

Cymbalta, marketed and manufactured by Lilly, is the subject of a lawsuit in the US. Plaintiffs in the suit have claimed that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials, they also claim that Lilly manipulated medical literature and exaggerated the benefits of Cymbalta.

Meantime, the multi-billion dollar pharmaceutical company offer no help whatsover to those addicted to their product.

Here's some of the comments...

POSTER 1: Day one of lowering my dosage...scared for the days to follow but I refuse not to come off of this! I can do it!!!

POSTER 2:  Are you two using the bead method?

POSTER 1: No my doctors takin it slow but I'm doing it with the help of this homeopathic remedy soooo we will see I feel okay today...just scary cause I'm a student and work so I don't want my grades to be affected if I'm feeling the withdraw 

POSTER 2: Good luck to you. If it proves to be too much, consider the bead method. It's the safest way to wean off.

POSTER 1: I tried to come off a few years ago with only one drop down then compeltely off and it was the worst idea of my life!!! Got so sick 

POSTER 3: Bead method taking out a few beads or 1 bead at a time is the only way I know that minimizes dreadful withdrawal effects. Please keep us posted and best wishes.

POSTER 4: I'm on day of 5 of removing a couple of beads per dose as I take one at night and one in the morning, I never thought I could do this but I can and I will. You will be fine as long as you listen to your body and take it slowly, good luck! 

So, what exactly is the "bead method"?

Altostrata, who runs the hugely successful Surviving Antidepressants forum, explains...

Cymbalta comes in 20 mg, 30 mg, and 60 mg capsules. 

Cymbalta is tricky to taper. It does not come in liquid form and cannot be compounded into a liquid. To protect the drug, each bead inside the gelatin capsule has an enteric coating to protect the drug from stomach acid, which would destroy the drug. (It is absorbed further down in the digestive tract.) The pellets cannot be dissolved in any liquid without destroying the active ingredient.

You cannot crush the pellets or dissolve them in a solution -- the drug would never get into your system, it would be destroyed in your stomach and you would have immediate cold-turkey withdrawal.

The number of beads in each Cymbalta capsule will vary within a given dosage and across dosages. The capsules are filled by weight. Count your beads carefully. Put unused beads into a clean, dry, capped prescription bottle marked with the dosage of the original capsule and expiration date. You might want to use them later. Do not mix beads from capsules of different dosages, such as 30mg and 60mg.

Patients trying to stop taking Cymbalta are in a tough spot. No help from the manufacturer Lilly, no help from medicine regulators such as the FDA and MHRA, no help from their prescribing physicians

Lilly, the FDA and MHRA are fully aware of the problems patients are facing but do nothing.

So, it's down to support groups such as 'Cymbalta Hurts Worse' and 'Surviving Antidepressants', there are many more too.

R. Brent Wisner, of Baum, Hedlund, Aristei & Goldman, P.C, who are representing plaintiffs had this to say...

“We believe that Lilly’s warning that Cymbalta withdrawal occurs at a rate greater than or equal to 1% is deceptive.  It is just a sleight of hand.  One of Lilly’s own studies shows that over 50% of patients experience withdrawal when they stop Cymbalta.  1% is not 50%, not even close.  A drug label is not the place to play games with words.  It is a place to honestly inform doctors and patients about the benefits and risks of medicines so they can make informed choices.  Our clients feel strongly that they were betrayed by Lilly and we will do all we can to ensure their voices are heard by the courts.” 

The removing of beads to help in tapering from a prescription drug is a patient idea, it's an idea that was forced upon them because the likes of Lilly, the FDA and MHRA have just sat back thumb twiddling and buck passing. Meantime, patients are left to their own devices to try and taper from a prescription drug that they took on faith to help with a diagnosis that has no science behind it at all.

I feel for anyone starting on a tapering process of any antidepressant, particularly those types that have no liquid formulation to help patients withdraw slowly.

Here's the irony.

The definition of the word 'PATIENT' is split into two categories here.

NOUN: A person receiving or registered to receive medical treatment.

ADJECTIVE: Done in a careful way over a long period of time without hurrying.

Perhaps drug-makers and their agents (drug regulators) could define which one is applicable to consumers trying to withdraw from antidepressants.

If you, or someone you know, has suffered the horrific side effects of Cymbalta then you may be eligible to file a personal injury lawsuit. You can contact an attorney at Baum Hedlund here.

Bob Fiddaman.

Paxil: The Statute of Limitations Defence

The Article

Paxil Birth Defect Action Time-Barred, Fla. Federal Judge Rules

MIAMI — A Paxil birth defect action is time-barred under Florida law because the plaintiffs knew of a possible connection between their injuries and the drug more than four years ago, a federal magistrate judge has ruled.

On Aug. 12, Magistrate Judge Jonathan Goodman of the U.S. District Court for the Southern District of Miami found the mother had notice of the possible invasion of her legal rights by Dec. 20, 1997, when her doctor noted in her medical records that her son’s condition was “apparently due” to Paxil.

The Background 

On January 27, 2012, Iolany Ferez, filed, on behalf of her minor son, Andrew Plascencia,(AP) a product liability action against GSK in Pennsylvania state court. Ferez alleged that Paxil caused A.P. to be born with Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur.

Ferez gave birth to A.P. in 1996. Doctors noted at birth that A.P. had a heart murmur, and diagnosed him with a heart defect the next day.  A.P.’s heart defect was classified as a tricuspid atresia type II‐B, a condition that has required two corrective procedures and regular cardiology visits throughout his life.

According to court documents, Ferez suspected Paxil caused A.P.’s heart defect almost immediately because she had taken it throughout the first six weeks of her pregnancy with A.P.She had not taken anything during her first two pregnancies and both children were born without defects.

Ferez asked A.P.’s cardiologist and her gynecologist whether Paxil may have caused A.P.’s heart condition. Both responded that they did not know.

On December 20, 1997, Dr. Marcio Ferez, Ferez’s father, employer, and primary care physician, noted in Ferez’s medical records that A.P.’s heart defect was “apparently due to” Paxil. In September 2005, GSK mailed a letter to Dr. Ferez and other healthcare professionals advising them of a recent study that showed Paxil was associated with an increased risk of congenital malformations, most commonly cardiovascular. A second letter was sent in December 2005, advising of an additional study showing an increased risk for cardiovascular malformations in infants born to women who had first trimester Paxil exposure.

The GSK Defence

GSK argued that the statute of limitations bars the claim of Ferez because she had actual and constructive knowledge that A.P.’s heart defect may have been caused by Paxil.

Conclusion

Although the Court was sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, “liability cannot rest on sympathy alone.”

GSK’s summary judgment motion was granted. (granting summary judgment to defendant in products liability case based on statute of limitations).

Commentary

Iolany Ferez took Paxil during her pregnancy. Her  son was born some time later and it was found that he had a number of birth defects. Ferez put two and two together and came to the conclusion that Paxil may have caused these defects because she had given birth on two previous occasions to healthy babies where, during these pregnancies, she was not taking Paxil.

GSK have claimed that because Ferez made an assumption that it could have been their product that caused her son's defects and didn't file a lawsuit against them straight away, she is out of time to make any such claim for compensation.

Can you imagine if victims of Jimmy Saville, or any other pedophile for that matter, were told that they, or the prosecuting team, couldn't bring any charges against him because they never came forward at the time of the alleged assault?

The Judge ruled in favour of Glaxo, "Although the Court is sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, liability cannot rest on sympathy alone."

So, an acknowledgement by the man with the gavel that Paxil may well be responsible for this particular child being born with a birth defect...but, um, tough shit, his mom  should have joined the dots and filed earlier.

What kind of system is this?

Sadly, Judges are bound by statute instead of common sense. Knowing the statute of limitations inside out is a must for any attorney representing the pharmaceutical industry. They cannot defend the drug because physical evidence shows the harm the drug causes - instead they rely on a statute that was, in my opinion, designed to help the mighty to continue being mighty and for the lowly to know their place.

In the meantime, the son of Ferez, who has Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur, has to go through a life of uncertainty. His mom has to pick up all the medical bills which can run into many thousands of dollars.

GSK have once again shown that their corporate motto that GSK is a  "global healthcare company that is committed to helping people to do more, feel better and live longer", is misleading and should be altered accordingly.

How have they helped the son of Iolany Ferez to do more?

How have they helped the son of Iolany Ferez to feel better?

How have they helped the son of Iolany Ferez to live longer?

This isn't the first time GSK have used a statute of limitations defence. They did so in the case of Joanne Thomas.

Thomas had to abort her fetus due to a number of defects caused by Paxil.

GSK argued she was out of time filing a lawsuit, the Judge agreed.

Research, carried out by myself and Thomas, showed that she wasn't out of time and that GSK knew that she wasn't. Attorney's involved in the case drew up a settlement between Thomas and GSK. There was no media coverage, apart from my own, about Glaxo knowing that Thomas had contacted them via email many years before she filed suit.

It's unknown if Thomas agreed to settle. Good luck to her if she did.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Bob Fiddaman.

Eli Lilly to Face Cymbalta Lawsuits

Eli Lilly and Company are facing a number of lawsuits regarding their antidepressant Cymbalta [Duloxetine]

Consumers of the drug, which is also used to treat various pain disorders, are claiming that Eli Lilly misled them about the withdrawal side effects of Cymbalta, side effects which include, but are not limited to electric-shock like sensations in their body and brain (also known as “brain zaps”), dizziness, nausea, vomiting, vertigo, excessive sweating, insomnia, nightmares, and diarrhea.

Over 20 lawsuits have been filed in federal courts across the US which sees claims that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials.

According to the LA law firm Baum Hedlund, the label wrongly claims that Cymbalta only has a 1% withdrawal risk, when in actual fact Cymbalta studies show a much higher risk rate - between 44% to 50% withdrawal risk!

Plaintiffs also claim that Lilly manipulated medical literature and exaggerated the benefits of Cymbalta.

Plaintiffs are being represented by by Baum, Hedlund, Aristei & Goldman, P.C., along with Keller Rohrback L.L.P. and Pogust, Braslow & Millrood.

“We believe that Lilly’s warning that Cymbalta withdrawal occurs at a rate greater than or equal to 1% is deceptive.  It is just a sleight of hand.  One of Lilly’s own studies shows that over 50% of patients experience withdrawal when they stop Cymbalta.  1% is not 50%, not even close.  A drug label is not the place to play games with words.  It is a place to honestly inform doctors and patients about the benefits and risks of medicines so they can make informed choices.  Our clients feel strongly that they were betrayed by Lilly and we will do all we can to ensure their voices are heard by the courts.” - R. Brent Wisner, Baum, Hedlund, Aristei & Goldman, P.C

Struggling to come off a psychiatric drug is a scary experience, it can lead to akathisia, which is a known precursor to suicidal thoughts and acts.

The electric-like zaps are something I personally endured when coming off Seroxat [known as Paxil in the US] - basically, it feels like your head is being zapped with a cattle prod, it's your brain's way of saying 'FEED ME'... it's the reduction of the drug compound that causes this effect, something that Glaxo and, in this case Eli Lilly, kept from the consumer.

The full press release can be read here.

If you, or someone you know, has suffered the horrific side effects of Cymbalta then you may be eligible to file a personal injury lawsuit. You can contact an attorney at Baum Hedlund here.

Baum Hedlund has litigated over 4,500 antidepressant personal injury and wrongful death cases against pharmaceutical companies.

Bob Fiddaman

Litigation - Disclosure of Documents

I decided to look into the law/rules of disclosure of documents and found it fascinating. Law fascinates me, it also makes me laugh, at times, because it can be so perverse.

Anyway...


Disclosure Of Documents

If you are a party to a litigation you are required to share information with your opponent. This includes documentation that supports your case and documentation that can potentially be detrimental to your case.

This process, known as disclosure, requires parties to make all documentation relevant to the matter in dispute available.  The objective aim being to enable the Court to ensure that justice is done.

Pre-action disclosure

Before commencing proceedings parties are required by the pre-action protocols to share information.

Standard disclosure

Standard disclosure requires the parties to carry out a reasonable search for documents which record information that they intend to rely on, or which adversely affect or support another party’s position.

The parties are required to search for all documents that relate to the issues in dispute.


"Parties should remember that the disclosure obligation continues until the proceedings are concluded.  The duty does not simply come to an end once the initial disclosure process has been complied with.  If a relevant document comes to light after initial disclosure, or even if it is created after initial disclosure, it must be disclosed." - David Rosen, Head of Litigation, Darlingtons Solicitors LLP


I'm unsure what would happen if a party was found to have not adhered to the above. Is it a criminal offence? Could a Judge call for a mistrial if he/she were to find out that one of the parties [let's say defence] had withheld information on purpose because it was of benefit to the prosecution and detrimental to the defence?

Fascinating stuff. It doesn't go on today though... or does it?

It would make quite a story if it did, don't you think?

Fraudulent concealment (1) , I'm sure, would be frowned upon by many Judges, particularly those in the Supreme Courts.

Bob Fiddaman

(1) Fraudulent concealment - Deliberate hiding, non-disclosure, or suppression of a material fact or circumstance (which one is legally or morally bound to reveal) with intent to deceive or defraud in a contractual arrangement. 

What's With GSK's Attorneys?

Bizarre behaviour coming from King & Spalding, GSK's highly paid defence lawyers.

No sooner was the year over when they were checking me out to see if I had wrote anything on a particular Paxil birth defect case that they successfully argued. [Fig 1]

Fig 1

What's up K&S, is something niggling at you?

What possible information do you think I have that you don't have?

Great question huh? If you, as [ahem] respected attorneys had information detrimental to your defendant you'd still be obliged to hand it over, wouldn't you?

I'm left wondering who are the bad guys here, is it GSK or is it their attorneys King & Spalding?

That's a question I will ask soon.

I've wrote a 16 page blog post entitled, "Ryan, Glaxo's Non-Viable Fetus". I've been sitting on it for some time out of respect for the mother concerned.

You see I, just like King & Spalding, know how to play the game. I know the mechanics of the waiting game GSK and their lawyers play. I know that litigation isn't about justice, it's just about getting the best deal for all concerned. I know that neither GSK or King & Spalding want this particular case to go to trial again and I know they will use delay tactics to their advantage to grind the plaintiff down. I think this woman has been through quite enough but she remains strong.

As for the information I hold and how I obtained it... well, that's a story just waiting to be told.

I can wait.

Meantime, this is for King & Spalding. (Not so much of a mystery girl anymore, eh guys?)

You know how to contact me.

Bob Fiddaman

Alistair Benbow on Seroxat/Paxil Suicide

As a follow on from my last post, Alistair Benbow on Seroxat/Paxil Addiction, I now turn my attention to part two of the interview with Benbow, much of which never went to air on the BBC.

For those that don't know, Alistair Benbow was the spokesperson, nae mouthpiece, for GlaxoSmithKline any time an issue of Seroxat [Paxil] was raised in the media.

Here's Benbow being grilled by BBC's Shelley Jofre over Seroxat and the suicide link.

The transcript was downloaded via the Drug Industry Document Archive


Key:

Q = Jofre
A = Benbow


Transcript GSK Tape - Panorama Interview - Dr Alastair Benbow 9 October 2002




Q. Let us move on. What has the company done about the Wyoming verdict?

A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed...


Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.

A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.


Q. So the jurors got it wrong!

A. No, I am not saying that. What I am saying - as I have said before - is that there is a confidentiality agreement between the family and GSK in this matter and I cannot comment on the specifics of this but we remain firmly convinced that Seroxat did not cause the tragic events in this case.


Q. It was pretty clear-cut. There was nothing else to explain his behaviour. He had only been on the drug two days and he clearly had a reaction that threw him into mental turmoil and made him behave in this way.

A. Yes, but there is a lot of speculation in the question you asked there but as I said I cannot comment specifically on this case because of a confidentiality agreement between the family and GSK. What I can say is that looking at all the data and the clinical trials there is no reliable evidence that Seroxat causes violence, aggression or homicide.


Q. All the evidence was produced in the trial. I am sure your company more or less produced the best evidence that was available. The jurors decided Seroxat was responsible for those four deaths and that is pretty serious.

A. As I have said before, I cannot comment on the specifics of the case...


Q. You cannot tell me that the clinical trials support Seroxat as not being linked to aggression or suicide?

A. Yes, I can say that. The clinical trial data and spontaneous adverse event data for reporting over the last ten years since Seroxat was made available in the UK do not support the finding that Seroxat causes aggression, violence or homicide.


Q. All of this data was presented to the jurors so they had ample opportunity to hear arguments on both sides and they felt Seroxat was responsible for the deaths.

A. As I say I cannot comment on the legal situation because of a confidentiality...


Q. I am not asking you to comment on the legal situation. I am asking you to comment on the fact that your company's drug was found responsible for four deaths.

A. As I said, I cannot comment on the specific situation but what I can say, quite clearly, is that when you look at the data from clinical trials and from the data in use in tens of millions of patients in 1999 that there is no reliable evidence that Seroxat causes violence, homicide or aggression.


Q. Is your company just going to ignore this verdict as if it never happened?

A. No we take very seriously any event that occurs when patients are taken off...


Q. What have you done to make sure that this does not happen again?

A. We have looked very, very carefully at the data, and as I say the data clearly shows that there is no reliable evidence that Seroxat causes violence, aggression or homicide.


Q. What does the warning in the patient leaflet mean then?

A. What do you mean?


Q. The warning about self-harm and suicide that is on the Seroxat leaflet, what does it mean?

A. As you will know, in patients who are depressed there is a significant risk of suicide and self-harm. That risk of suicide is at its worst when people have their worst depression, and that is often when people go to the doctor...


Q. Why would the risk of suicide increase once they start taking Seroxat?

A. No, I am not saying it increases when they start to take Seroxat; I am saying people are at risk of suicide early in treatment because it takes a while for an anti-depressant to work.


Q. The suggestion in the warning is that there is an increased risk in the first few weeks of being on Seroxat, but you say it is nothing to do with your drug?

A. What I am saying is that there is an increased risk of suicide early in the treatment of depression. Whatever the treatment, or indeed if there is no treatment there is an increased risk of suicide, and this is a very...


Q. So it is just a co-incidence that the increased risk of suicide starts when they start taking Seroxat?

A. No, what I am saying is that there is an increased risk of suicide even if patients receive no therapy. This is a fact of people who have depression. The reality is that many people with a severe depression have a very low mood and loss of energy. As people start to recover their energy and mood encourages...


Q. But they are not recovering, you say, until a few weeks after they start the Seroxat.

A. Early on in treatment the major affects of anti-depressants take a week or two to start, but the reality is that energy levels are one of the first things that start to improve, but mood comes later.


Q. Is it not that they get agitated?

A. Not at all. Not at all.


Q. It sounds to me here as though you are trying to have it both ways. You are trying to say the risk increases when you start taking the drug but it is nothing to do with the drug. It is meaningless warning.

A. No the warning is there, and has been agreed with the regulatory authorities, and it is basically to tell doctors, 'Look, you have a patient who is depressed. They are at risk of suicide. Don't just think just because you have started them on anti-depressants that they are not going to remain at risk of suicide immediately. The fact is that antidepressants take a while to work. If you look at the data what does the data show? The data shows that Seroxat reduces suicidal ?hydration and thought. Over the past ten years - or the ten years between 1990 and 2000 - with the increasing use of antidepressants, suicide rates in England and Wales have fallen by 15%...


Q. Are you taking credit for that?

A. I am saying that the increased used of anti-depressants, the better diagnosis of depression and the better treatment that is available - yes, that has contributed to the fall in suicide rates.


Q. Perhaps over the long term drugs like Seroxat are useful for avoiding suicide and reducing suicide rates but what we are talking about is a window in the first few weeks where there is quite a lot of evidence that people can become agitated, restless and anxious. It seems to correspond exactly with the period that you are saying there might be an increased risk of suicide but you are saying it is nothing to do with your drug.

A. No, I must disagree with the comments you made. There is not a lot of evidence to suggest that patients are getting agitated and restless and anxious. The reality is that anti-depressants do take a short while to work, and during that first few weeks, when patients are taking therapy, doctors should be aware that patients are at risk of suicide, because of their underlying depression.


Q. So it is not an increased risk. I do not understand what you are saying. If you are saying, 'Until the anti-depressant starts working they are at the same risk of suicide as they have always been' then that is one thing. However, your warning says there is an increased risk of suicide...

A. What I am saying is the greatest risk to patients of committing suicide is in those who are severely depressed.


Q. But in those first few weeks of... [talking simultaneously] start Seroxat?

A. No, the most severely depressed patients are those that have just presented their doctor and just started on therapy.


Q. Of course not everyone take Seroxat for depression and we have spoken to someone who took Seroxat for panic attacks and he began to self-harm in the first few weeks of taking it, something he had never even dreamed of doing before.

A. Seroxat is indeed available for a range of depression and anxiety related disorders, all have clear criteria for laying down exactly what the conditions are. There is a range of different conditions - panic disorder, obsessive-compulsive disorder, social anxiety disorder etc. Many of them are associated with depression and the same patients will be at risk of suicide and...


Q. Again is it just a coincidence this behaviour would start a few weeks after taking Seroxat?

A. No I am not saying it is a coincidence. I am saying it is a reality of depression and other related disorders...


Q. Panic attacks?

A. Yes, panic attacks and...

Q. I thought that is a link to self-harm.

A. Panic attacks are linked to depression, which is linked to self-harm.

**At this point Jofre pushes home the point about Seroxat withdrawal - She then continues with...


Q. Well, let us move on. Here is a drug that is linked to suicide and self-harm, a drug that thousands of people say they are addicted to; do you seriously think it should be given to children?

A. Let me just correct something in your question. There are a number of allegations you made there none of which are correct. In terms of whether we think Seroxat should be made available to children, absolutely. Two percent of children, 4% of adolescents, will develop depression. The adolescents are at particular risk of suicide.


Q. You think this is safe for children?

A. I think we need to do the trials to determine this. We have an obligation to make our medicines available to those patients at need. Adolescents are some of the patients who are most at need of anti-depressants. Suicide in adolescents is the third leading cause of death. Do not trivialise depression for those patients. We have a strong obligation to study our medicine in these patients to see if we can help them.


Q. In a recent study that Glaxo funded more than 10% of children developed psychiatric problems within eight weeks of taking Seroxat.

A. I think you will have to tell me a little more about the specific study so that I can understand your question.


Q. It was funded by Glaxo and carried out in America - the biggest ever study of Paxil in depressed children and more than 10% of children developed psychiatric problems within a few weeks of taking Seroxat.

A. I think in any study a proportion of patients (as in this particular study) where patients were either taking Seroxat, or Imipramine, or a placebo, a proportion of patients will develop adverse effects in the course of the study.


Q. There were far more children on Seroxat than on the other drug, or on sugar pills who developed these psychiatric problems.

A. There are a number of different elements that you lump together in psychiatric disorders.


Q. I will run through the list of problems if you like. Five of the children suffered suicidal thoughts and gestures. There was aggressiveness. There were behavioural problems at school. None of this sounds very safe; it all sounds quite worrying for the children who are on Seroxat.

A. Actually not because some of those symptoms were also seen on the patients taking Imipramine and placebos.


Q. Not as frequently.

A. Maybe not as frequently, but they still suffered. This is typical of the sort of symptoms that occur in this population of patients. This is a difficult population to treat and you will be aware that for many medicines there is no licensed implication for use in children so much of prescribing in children is done off-label. We firmly believe that we have an obligation to study our medicine to treat population to examine the safety and the efficacy of that medicine.


Q. I appreciate that but there were many problems on Seroxat than on the other drug or the sugar pills.

A. Actually the majority of those side effects were relatively minor.


Q. No, a lot of these children were hospitalised it was so serious.

A. If you look at the proportion of patients who withdrew from therapy - and you can see less than 10% had to withdraw from Seroxat - more than 30% withdrew from the other active therapy and just under 10% withdrew from the dummy.


Q. It is heart complaints with the other drug, and I understand that, but-

A. But that is the sort of therapy that is the alternative, which is why it is very important that we study Seroxat in this group of children who are most at risk from suicide.


Q. What we are talking about here though are psychiatric side effects, the sorts of side effects that can lead to suicide and there were far more children on Seroxat suffering these problems than on the other drug or sugar pills.

A. What you are trying to do is make a link here with the adult data. The adult data clearly shows that there is no reliable scientific evidence that Seroxat causes suicide.


Q. But why should it be that so many more children should suffer these side effects on Seroxat than the other drug or sugar pills.

A. Actually, if you look at the more serious of those side effects the number difference was very small, and the sort that you would expect to see in clinical trials. On one trial there may be more than on another, in another it will go the other way.


Q. And for the 10% of the children on Seroxat who had these side effects you are not worried that it was caused by the drug?

A. The vast majority of these patients did not have side effects significantly enough to withdraw from the treatment. The reality is that in this population depression is an extremely serious condition and in many cases leads to suicide.


Q. I appreciate that.

A. Are we worried by the side effect profile? We take the safety of our medicines extremely seriously and we will look very carefully at this, and the combination of other data, to decide whether this medicine is suitable for children. My belief is that it will be but because there is a lack of treatment for this serious condition that this medicine will be suitable for a range of children as well as adults.


Q. You cannot be sure that the 10% of children on Seroxat who suffered these problems did not suffer them because of Seroxat can you? You cannot be sure about that.

A. One can never be sure of anything in medicine, but just because you take a medicine and you get an effect does not mean to say cause and effect because the same sort of symptoms occur with the dummy pills.


Q. That is why if you compare it to another drug and the sugar pills, in that comparison Seroxat was much worse.

A. In that comparison the proportion of patients withdrawing from the study due to adverse events was much lower on Seroxat than one of the other potential treatments available.

Q. There are 60 psychiatric side effects - the sorts of side effects that are linked with suicide and self-harm.

A. Let us look at the totality of the adverse event profile because it is the total risk and input that is important.


Q. We are considering the link with suicide, and this evidence points very strongly to the fact that more children are suicidal and had suicidal gestures in fact on Seroxat than the other drug.

A. With respect the totality of the data is important. What you are talking about are five patients out of the 275 on Seroxat, three patients on Imipramine. That difference is not significant and one patient had a placebo.


Q. No, I am talking about five children. The figures are-

A. I have given you the figures. Five on Seroxat, three on Imipramine and one on placebo.


Q. There were children out of 93 children on Seroxat who had suicidal thoughts and gestures, another five out that 93 had serious psychiatric side effects. Do you not think parents would be worried about that if their child were to be given this drug?

A. I believe that what parents would be more worried about is the risk that their children had of committing suicide and other symptoms of severe depression if no treatment was available. In my opinion parents want treatments to be properly evaluated during clinical trials before their children are given any medicine.


Q. But the evidence here suggests that their children might be at more risk of suicide if they go on Seroxat.

A. No, the evidence is not there. There is no statistical difference between the groups. The reality of the situation is that in this trial Seroxat was generally well tolerated by this difficult to treat population.


Q. You are not concerned about this and you do not think parents should be concerned about this?

A. What I am saying is that we are attempting to study Seroxat in this difficult to treat population. If, and when, we demonstrate the efficacy and the safety of the product, then the data will be submitted to the regulatory authorities with a view to getting a licence so that these patients and their doctors have another treatment available to them to treat this difficult disease.


Q. You would like it to be licensed for children?

A. Of course it must be driven by the data. There are many times we do clinical trials where you find that the balance of risk and benefit is not capable, in which case you do not try and get a license. The reality in this situation is the data we have generated so far is favourable. There is more benefit than risk in this population but until we have developed all the clinical trials, and done a full package of information, and adequately studied this drug in this population we cannot say that.


Q. Are you satisfied then that your company, generally, has done everything it can to keep patients properly informed about the negative side of the drug?

A. Absolutely, and it is not something we just sit and watch. Our summary of product characteristics is a living document. You start with a very limited number of healthy volunteers. Then you develop the clinical trials in thousands of patients. Then you make it available to tens of millions of patients around the world. As time moves on you collect more information and more data becomes available, and as a result we regularly change the information, which we provide to prescribers and patients for all our medicines, and of course for Seroxat as well. We will continue to do that. We will continue to monitor the safety of our medicines. We will make changes to the information to prescribers and patients, driven by facts and data not by anecdote.

Interview ends.



Less than one year after this interview a review of Seroxat data by the Committee on Safety of Medicines (CSM) showed that children taking tSeroxat may be more likely to self-harm or partake in suicidal behaviour. The Medicines and Healthcare products Regulatory Agency (MHRA) has also warned that adults who are on the drug should not suddenly stop taking it.

The review found that studies on more than 1,000 children also suggested those on Seroxat were at least twice as likely to have suicidal thoughts or self-harm compared to children with similar mental health problems who are not taking the drug.

Ironically, they only found this evidence after GlaxoSmithKline had sent in data because they wanted the MHRA to grant a licence for Seroxat to be used in children.

It was estimated that between the period of Alistair Benbow's interview with Shelley Jofre and the release of the news that Seroxat could cause suicide in kids, 8,000 patients under the age of 18 were treated with Seroxat in the UK.

In 2007, the BBC aired its fourth Panorama documentary regarding Seroxat.

On Monday January 29, 2007 Panorama showed shocking footage that demonstrated how GlaxoSmithKline's Public Relations people and marketing department 'spun' negative trial results on children which showed serious risk of suicide, self-harm and aggression.The trial also indicated Seroxat was no more effective than a sugar pill.

GlaxoSmithKline claimed to doctors that the drug was ‘remarkably' safe and effective for under-18s, with the support of an ‘independent' professor of psychiatry [Martin Keller] who earned $500,000 in fees from drug companies in one year.


Seven out of the 93 children in the Seroxat group had to be hospitalised for adverse reactions ranging from  self-harm, aggression, violence to others and suicidality (suicidal thoughts or actions, meaning actual suicide attempts)

In other words, almost 8% of children in the Seroxat group had the above adverse reactions.

What was it Benbow said in the interview?

"There is no statistical difference between the groups. The reality of the situation is that in this trial Seroxat was generally well tolerated by this difficult to treat population."

Was Benbow lying or was he not aware that data showed this significant [8%] figure?

In an internal company memo dated 14 October 1998, four years prior to Benbow's denial, GlaxoSmithKline executives concluded that Seroxat did not work and that a licence application would be refused: ‘The results of the study were disappointing. The possibility of obtaining a safety statement was considered, but rejected.' The best they felt they could achieve was a statement that 'although safety data was reassuring, efficacy had not been demonstrated'.

Did they go public with this?

Nope.

The self-harm, aggression and suicide attempts were kept quiet as was the lack of efficacy of Seroxat in children. PR people took over to implement a new plan: promote Seroxat to doctors as a treatment for under18's.

GSK's plan was simple and, it has to be said, unethical. They tried to persuade doctors that Seroxat was suitable for their child patients. From the 1998 internal memo showing that efficacy had not been demonstrated they spun the whole trial on its head with the clear message that Seroxat was ‘remarkably effective and safe for children'.

How did they do this?

KOL's - key opinion leaders in the field of child and adolescent psychiatry.

Martin Keller was, at the time, a renowned expert in the field of child and adolescent psychiatry. If Glaxo could get Keller to endorse the use of Seroxat in children then they were on to a winner.

Enter the ghostwriting machine.

Glaxo hired a PR firm to draft an article claiming Seroxat was beneficial for children. Keller put his name to the article which was later published in widely read journals. Job done, suicidal attempts, aggression and self harm were all hidden.

GlaxoSmithKline simply buried the data, including data from another, later trial on children which found that the placebos given to the control group of depressed kids ‘worked' better than Seroxat!

Glaxo later, forced by US medicines regulator the FDA to re-evaluate the raw data from Study 329, admitted to four further adverse reactions in which children became suicidal, raising the number suffering severe reactions to the drug from seven to 11 — a shocking 12 per cent of the total, and representing a 600% increase in events related to suicide.

Benbow knew nothing... apparently.

This half hour documentary goes into more detail about the whole sordid affair.

Bob Fiddaman

JOIN THE FIDDAMAN BLOG ON FACEBOOK